Alcohol-ROC-Training

Part of paid clinical trials in Berkeley, California.

Sponsor
Yale University
Study ID
NCT05491551
Status
Recruiting
Apply to this trial

Conditions

  • Binge Drinking
  • Heavy Drinker
  • Heavy Drinking
  • Young Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-Based Treatment-Regulation of Craving — BEHAVIORAL
    Participants will be trained in using the MBT-based mindfulness strategy as described above ("notice craving and accept the feeling without judgment or reaction"). Participants will then be instructed to think of accepting and non-reactive responses when they see the instruction "ACCEPT" during ROC-T. On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see ACCEPT and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale.
  • Cognitive-Based Therapy-Regulation of Craving — BEHAVIORAL
    Participants will be trained in using the CBT strategy by first considering and reading about the negative consequences of drinking. Participants will then be instructed to think of those negative consequences ("Focus on the negative consequences associated with drinking)" when they see the instruction "REFRAME" during ROC-T.On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see REFRAME and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale

Study Details

The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).

Key Dates

Start date
Sep 28, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness-Based Treatment
    Using mindfulness and meditative strategies to control craving
  • Experimental: Cognitive Behavioral Therapy
    Thinking of negative consequences to control craving
  • No Intervention: Control
    No regulatory strategy

Primary Outcome Measure

Change in frequency of heavy drinking days [ Time Frame: From baseline to 2-weeks post-intervention and to the 10-week follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, BerkeleyBerkeleyCalifornia94720
Hedy Kober, PhD
[email protected]
917-470-8331
Yale UniversityNew HavenConnecticut06510
Hedy Kober, PhD
[email protected]
917-470-8331
Corey Roos, PhD
[email protected]
2036235882

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By research site
University of California, Berkeley· Berkeley, CAYale University· New Haven, CT

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